SUPARTZ FX
FDA premarket approval P980044/S029 · decided 2015-12-10
Approval details
- PMA number
- P980044
- Supplement
- S029
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SUPARTZ FX
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Seikagaku Corp.
- Date received
- 2015-11-10
- Decision date
- 2015-12-10
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Tokyo
- Statement
- SHARING THE FACILITY AND EQUIPMENT USED TO MANUFACTURE SUPARTZ FX FOR THE PURPOSE OF MANUFACTURING OF AN INVESTIGATIONAL DRUG PRODUCT.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HADGEL, 4 GRAM/SYRINGE (K011544) | Seikagaku Corp. | 2001-08-15 |